Quality Systems Specialist

Essential Job Duties and Responsibilities

This position is responsible for leading and/or supporting Quality Systems, which includes Document Management, Training, Deviations/CAPAs, Audits, Change controls, Gap Assessments, Specifications, Quality Agreements, Quality Management review and Annual Product Reviews within the scope of the organization.

• Serves as a Quality Systems subject matter expert for the Wilson manufacturing site
• Facilitates and/or supports the Change Control Board, Change Control Review Board, and CAPA Review Board to ensure business, quality, and compliance goals are met
• Provides support and direction to all departments regarding specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standards
• Provides support and direction to all departments in respect of document control to ensure business, quality and compliance goals are met
• Partners with other departments to ensure all Quality systems and associated programs are completed in an efficient and compliant manner
• Performs tasks related to the management of document control and records management in respect of SOPs and other GMP regulated documents
• Receives and logs documents submitted by site personnel for inclusion into the document control system
• Reviews received documents for conformance to site systems in respect of format, numbering, etc.
• Liaises with document owners in respect of approval schedules and implementation of new or revised documents
• Provides feedback from document review to the document owners
• Performs tasks related to the administration and management of all relevant Quality systems with respect to local and global SOPs and other GMP regulated documents
• Receives access requests submitted by site personnel for inclusion in appropriate electronic quality systems
• Reviews and manages access gained by personnel for quality systems
• Provides feedback to global process owners regarding continuous improvement to quality systems
• Performs tasks related to administration of the Electronic Document Management System at the site with the guidance of the Quality System Manager
• Adds new users to the system and assigns privileges, as required and after requirements have been fulfilled
• Sets up review and approval routings for SOPs and other GMP regulated documents
• Tracks documents through the review and approval processes and advises relevant personnel accordingly
• Participates in upgrading activities of the system as appropriate
• Generates reports from the system
• Develops and applies systems and procedures related to the Electronic Document management System at the site
• Carries out tasks related to the administration of site deviation management, change control management, and training systems using an Electronic Tracking System (ETS) with the guidance of the Quality System Manager
• Adds new users to the system and assigns privileges, as required and after requirements have been fulfilled
• Participates in upgrading activities of the system as appropriate
• Generates reports from the systems, as requested
• Assists Quality Assurance with specifications, quality agreement, and gap assessment activities within the scope of the organization
• Supports Management review (QSMR), documentation management, annual product review and validation compliance activities, as needed
• Responsible for managing the assigned Quality Systems Metrics and supporting the implementation of all quality policies, procedures, and systems to assure compliance with Regulatory and Company requirements
• Provides or supports Good Documentation Practice (GDocP) and GMP training to site personnel as directed by the Quality Systems Manager
• Develops and maintains training materials for provision of GDocP and GMP training to site personnel of applicable systems
• Supports Inspection readiness at the site
• Performs tasks related to the storage and archiving of documents related to BioNC
• Prepares and catalogues documents for archival
• Coordinates with internal and external groups for the archival of documents
• Manages document retrieval from archive storage as requested
• Regulates access to on-site document storage
• Audits internal and external document storage/archive systems
• Partners with Learning & Development department in the provision of training in Good Documentation Practice (GDocP) and GMP to site personnel with the guidance of the Quality Systems Manager
• Coordinates periodic review of all GMP documentation with site personnel
• Manages the record retention program as it applies to global and local requirements
• Supports in inspection readiness as a documentation and records management SME
• Serves as a delegate for Quality Systems Manager, when appropriate
• Performs related duties as assigned by supervisor
• Maintains compliance with all company policies and procedures

Minimum qualifications

• Bachelor’s degree in a scientific, engineering, or technical discipline is required
• Minimum of 2 years of experience working in Quality and/or Compliance in the pharmaceutical industry
• Minimum of 2 years of experience managing workflows within electronic quality systems such as Track Wise, Master Control, Veeva, Compliance Wire, Success Factors, ZenQMS, or Documentum
• Minimum of 2 years of experience leading or managing the elements of quality systems (deviations/nonconformances, change controls, training, documentation, annual product reviews, and gap assessments)
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals and ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position

This role is onsite.